Mr. Peter Hurst
Lincolnshire PE12 6DP
Skills And Services Offered:
I offer a quality medical writing and editing service for the pharmaceutical industry, specialising in producing documents in CTD format for regulatory submission including:
- Clinical Study Reports (Phases I to IV)
- Expert Reports/Clinical Overviews
- Integrated Summaries of Safety and Efficacy
- Investigator's Brochures
- Patient Information Leaflets
- Summaries of Product Characteristics
- Product Packaging and Labelling texts
- Product Monographs
- Periodic Safety Update Reports
- Advisory Board proceedings
- Educational/Marketing materials
- Papers for publication in Journals.
Editing and Quality Control
I also offer a document editing and Quality Control service.
I have a well-equipped home office and I am also able to work on site.
Translation of pharmaceutical documents from German into English.
All therapeutic areas covered. Experienced in the following specialist areas:
- CNS - particularly Parkinson's disease
- Oncology - including vaccines
- Cardiovascular - particularly hypercholesterolaemia
- Smoking control
- Women's health
- Antispasticity drugs
- Overactive bladder syndrome
- Multiple sclerosis (NICE documents)
- Wound Management products.
My full curriculum vitae is available on request.
I have 25 years of relevant experience comprising:
- Five years working as a Medical Writer for major international pharmaceutical companies.
- Twelve years working freelance including:
- three years working as a Regulatory Affairs Consultant for GlaxoSmithKline
- one year working as a Regulatory Affairs Consultant for Bristol-Myers Squibb Pharmaceuticals
- one year working in the Corporate Communications Team at SmithKline Beecham.
- Three years working for the Medicines and Healthcare Products Regulatory Agency.
- Five years working in a research laboratory at the London Hospital Medical College, where I developed assay methods for pharmaceuticals.
I have presented and published my own research.
- Upper Second Class B.Sc. Honours Degree in Pharmacology from the Welsh National School of Medicine/University College Cardiff
- Member of the European Medical Writers Association (EMWA)
- Member of The Organisation for Professionals in Regulatory Affairs (TOPRA)
- Founder Member of the European Wound Management Association (EWMA)